NSF International White Papers

THE FUTURE OF THE PHARMACEUTICAL INDUSTRY
YOUR CHANCE TO CONTRIBUTE by Martin Lush
Ever participated in one of those benchmarking exercises? You know what I mean. When a (usually) fresh-faced consultant asks lots of questions and fills in a spreadsheet comparing what you do with your competitors. Well, beware.
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REVIEW OF EU ATMP GMP GUIDANCE
On November 22, 2017, the EU Commission adopted the Guidelines on Good Manufacturing Practice specific to advanced therapy medicinal products (ATMPs), as Part IV of EudraLex Volume 4. These guidelines come into force on May 22, 2018. When these GMP guidelines for ATMPs were first drafted, most of the manufacturers of ATMPs were critical of the guidelines being a separate guidance document rather than being an annex to the existing guidelines in EudraLex Volume 4. There were also criticisms from smaller academic and hospital units that the new guidelines place too much burden on these units in their rigid application of industrial type GMPs, which they argued was not practicable to these highly innovative products. Concern was also expressed that as the initial draft stood, the innovative research that was going on with ATMPs would be hindered in the EU.
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Data Integrity A Closer Look
Data integrity remains a perennial hot topic impacting the pharma biotech industry and the trend has been picking up steam; the number of data integrity-related warning letters has increased consistently since 2010. A number of new guidance documents came out in 2016 by FDA, MHRA, EMA PIC/S and the WHO and yet companies continue to grapple with data integrity issues.
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Hierarchy For Capa Effectiveness
Have you ever reviewed an investigation report and wondered whether the proposed corrective and preventive action (CAPA) would be effective?
Sometimes, we shrug our shoulders and say, “At least they put something in place”. We all know that the FDA expects us to include an effectiveness check, but do we have enough guidance to make these checks meaningful? NSF suggests that you consider these three questions:
1. What will you measure?
2. When will you measure it?
3. What is your acceptance standard?
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Is Fear of Risk Your Biggest Risk?
In this white paper, NSF International's Martin Lush gives his insights into the pharmaceutical industry's relationship with risk. It includes five steps to help you become risk smart.
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Risk Assessment: A Closer Look
NSF International’s Andy Barnett takes a deeper look into ICH Q9, Quality Risk Management, with particular focus on the failure mode and effects analysis tool for risk management.
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Aging Facilities
Aging facilities is a trendy catchphrase that has taken hold in the biopharmaceutical industry. This white paper by NSF International’s Nicholas Markel provides a few questions to determine if you have an aging facility as well as how to address any issues you may have.
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NSF: Global Selection Considerations for CMO When Conducting Due Diligence
Deciding to use a CMO requires a thorough due diligence exercise conducted both as desktop and on-site reviews. This NSF white paper by Maxine Fritz provides the fundamental factors to consider when engaging and deciding on a CMO.
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NSF: Time To Move Beyond Mediocre CAPAs and Make Them More Effective
Have you ever wondered why some of your CAPAs fail to achieve the desired improvement? Wouldn’t it be nice if there were a way to evaluate the CAPA before you implement it? NSF proposes the use of our CAPA hierarchy, which will help investigators select a CAPA that is most likely to deliver the desired outcome. Read the white paper for more information on the hierarchy and find out how else to use it.
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Do you have a robust and compliant CAPA System?
Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.
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How to write to Regulatory Agencies when things go wrong
Your essential guidance on what to do next after you receive a less than positive regulator's audit report.
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NSF asks why Annex 1 is Important to you
This white paper details the key reasons for the revision to EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. It outlines what you should be asking yourself regardless of the dosage form you are responsible for. It also includes a simple tool to assess the impact on your organization when there is a regulatory change.
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Heightened FDA Enforcement for Sterility Issuesin Pharma Biotech with NSF
NSF analysed all of the warning letters issued to pharma and biologic manufacturers for sterility issues since 2015. This white paper provides detailed insight into our analysis. It includes relative charts and a table with a summary of the regulations cited by the FDA as well as recommendations for closing your compliance gaps.
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NSF: Essential Rules When Investigating GMP Deviations During Sterile Processing
This white paper by John Johnson outlines the key attributes to consider during sterile products manufacturing. It also details five key non-negotiables for investigating pharmaceutical GMP deviations or deficiencies in sterile processing.
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NSF Explains the Points to Consider when Auditing a Terminally Sterilised Drug Product
When conducting an audit of the terminally sterilized pharmaceutical product process, the essential checklist outlined in this white paper by Maxine Fritz will help.
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NSF - Site Director: KPIs Should Look Forward as well as Measure Results
A Site Director expresses his views on how to use KPIs most productively.
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NSF asks a Production Director for their views on moving forward with KPIs
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics
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NSF determines what KPIs mean for Employees
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures
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NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.
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Tech Talk: Changing GMP Behaviours with NSF
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.
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NSF: KPIs and the Head of Corporate Quality: KPIs Are Essential for a Successful Product Release
What are your views on KPIs? Essential or a necessary evil?
“They are absolutely essential, providing they are good! I remember during a regulatory inspection I was asked every QP’s most feared question: How do you know everything is in control before you release product?
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NSF: Learn from a Fabulously Successful GMP Remediation Program
This White Paper describes a remediation program that appeared at first to be impossibly daunting, expensive and unattainable. The company had received a range of critical and major GMP deficiencies from the UK regulatory body, MHRA, and was facing a referral to MHRA’s Inspection Action Group. Manufacturing had to be suspended pending a risk assessment of the non-compliances; evaluating the effect of the non-compliances in terms of risks of misbranding and adulteration of the products. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.
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NSF: Remediation of Pharma Quality Systems – It’s All About the People
Much of NSF Pharma Biotech Consulting’s work involves helping companies remediate flawed quality systems.
This is usually done as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do ‘whatever it takes’ without a full understanding of what that means. While expansive in concept, ‘whatever it takes,’ for many, means simply deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.
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Brexit Implications for UK Pharmaceutical Administration with NSF
With the historic vote by the UK to leave the European Union we have been asked by many of our clients and colleagues “What will the vote to leave the EU (Brexit) mean for pharmaceutical quality management and the role of the Qualified Person (QP)?”
The only thing that is certain is that we are facing at least two, and probably more, years of unprecedented uncertainty.
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NSF: Techniques to tackle our current Complexity Crisis
Over the last 30 years we have seen levels of complexity in the pharma industry increase dramatically. It’s getting close to a crisis point. Although some complexity is triggered by events we can’t influence (regulations, globalization and the like), most is created by choice.
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What NSF’s Remediation Projects Are Saying About the Industry
NSF Pharma Biotech Consulting is in a unique position in that our team is regularly and intimately involved in a range of GMP remediation projects across the world and across all dosage forms.
Offering companies a different perspective on current industry thinking or for us to review and verify that the proposed CAPA will be effective across the full range of key attributes. These attributes include cost, timeframe, GMP compliance, sustainability, simplicity and ease of presentation to clients and regulators.
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NSF: What Works and What Doesn’t When Changing your Quality Culture and Improving GMP Behaviors
Ever wondered why 70% of change initiatives fail, or why 95% of New Year’s resolutions are forgotten by February? The same reason traditional training methods have little impact on workplace behaviors, and why the “carrot and stick” (reward vs. punishment) approach to changing behaviors doesn’t work. In this article, we detail how to really change your quality culture and improve GMP behaviors.
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So How Is NSF Moving E.A.S.T.?
How does an organization stand out from the crowd in the global marketplace, where businesses vie for attention and custom, and a multitude of choices exist in every transaction? Communication that seeks a change in an organization has to be Easy, Attractive, Social, Timely (E.A.S.T)
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